Brand Names: U.S.

Nasonex

Propel Mini

Pharmacologic Category

Corticosteroid, Nasal

Pharmacology

May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins). Leukocytes and macrophages may have to be present for the initiation of responses mediated by the above substances. Inhibits the margination and subsequent cell migration to the area of injury, and also reverses the dilatation and increased vessel permeability in the area resulting in decreased access of cells to the sites of injury.

Absorption

Undetectable in plasma; clinical effects are due to direct local effect, rather than systemic absorption

Metabolism

Hepatic; extensive via CYP3A4 to multiple metabolites

Excretion

Bile (primary route); urine (limited)

Onset of Action

Improvement in allergic rhinitis symptoms may be seen within 11 hours; Maximum effect: Within 1 to 2 weeks after starting therapy

Half-Life Elimination

6 hours (IV)

Protein Binding

98% to 99%

Special Populations: Hepatic Function Impairment

Concentrations may increase with severity of hepatic impairment

Use: Labeled Indications

Allergic rhinitis (seasonal and perennial): Treatment of nasal symptoms of seasonal allergic and perennial allergic rhinitis in adults and pediatric patients ≥2 years.

Rhinosinusitis, treatment (acute, mild to moderate, uncomplicated)

Data from a randomized, double-blind, double-dummy, placebo-controlled study supports the use of intranasal mometasone in the treatment of acute, uncomplicated rhinosinusitis. Intranasal mometasone was more effective than placebo or amoxicillin in reducing major symptom scores. Symptomatic improvement occurred as early as day 2 of mometasone treatment [Meltzer 2005]. Additional trials may be necessary to further define the role of intranasal mometasone in this condition.

Contraindications

Hypersensitivity to mometasone or any component of the formulation.

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, the possibility of cross-sensitivity cannot be ruled out with certainty because of similarities in chemical structure and/or pharmacologic actions.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied)

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; drug accumulation may increase with severity of hepatic impairment.

Administration

For intranasal administration only. Prime pump (press 10 times or until fine spray appears) prior to first use. If 7 or more days have elapsed since last use, reprime pump with 2 sprays or until a fine mist appears. Shake before using. Blow nose to clear nostrils. Insert applicator into nostril, tilt head slightly forward keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray; exhale through mouth. After each use, wipe the spray tip with a clean tissue and replace cap. Avoid spraying directly into nasal septum, eyes or mouth. Discard after 120 medicated sprays have been used, even if bottle is not completely empty.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: When recommended doses are exceeded, or in extremely sensitive individuals, may cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis. Reports consistent with hypercorticism are rare. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.

• Hypersensitivity reactions: Hypersensitivity reactions including wheezing have been reported; discontinue if such reactions occur.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid exposure to chickenpox and/or measles, especially if not immunized.

• Local nasal effects: Nasal septum perforation, epistaxis and localized Candida albicans infections of the nose and/or pharynx may occur. Periodically examine nasal mucosa in patients on long term therapy; discontinuation of therapy may be necessary if an infection occurs.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment: drug accumulation may increase with severity of hepatic impairment.

• Infections: Use caution or avoid in patients with active or latent tuberculosis or in patients with untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex; worsening of these conditions may occur. Do not use in untreated localized infection involving the nasal mucosa; concurrent antimicrobial therapy should be administered if bacterial infection of the sinuses is suspected/confirmed.

• Appropriate use: Prior to use, the dose and duration of treatment should be based on the risk vs benefit for each individual patient. In general, use the smallest effective dose for the shortest duration of time to minimize adverse events. A gradual tapering of dose may be required prior to discontinuing therapy. There have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing inhalation therapy.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor. Intranasal corticosteroids are recommended for the treatment of rhinitis during pregnancy; the lowest effective dose should be used (NAEPP 2005; Wallace 2008).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.